FDA warns consumers to discard Zicam products

In an unusual move earlier this week, the Food and Drug Administration (FDA) alerted consumers that Zicam Cold Remedy products have been associated with long lasting or even permanent loss of smell. FDA recommends that consumers stop using these products and that they throw away any that might still be in their homes. The affected products include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size (the last one is a previously discontinued product). The products had been sold by Matrixx Initiatives to reduce the duration and severity of cold symptoms; however, they have never been shown to be effective.

These products were formulated and sold for intranasal use and may have contained zinc, which is potentially toxic to the nasal membranes. The FDA emphasized that their advisory does not concern oral zinc tablets and lozenges that are taken by mouth. Ironically, oral zinc products have long been used as attempted treatments for anosmia, the medical term for loss of smell. But it is widely understood in the medical community that intranasal zinc administration can cause a variety of problems with the sense of smell, up to and including its complete loss.

What’s unclear about the Zicam products is how much, if any, zinc they actually contain. That’s because they are marketed as homeopathic remedies, which typically contain little to no actual active ingredient. As I’ve explained in detail in my earlier blog entitled “Homeopathy is a scam!” these products start with an original active substance and then dilute them significantly. The theory is that “like treats like” but only when present in vanishingly small amounts. Typical homeopathic remedies are diluted to a point where essentially none of the original material is still present. But in the case of the Zicam products the dilution factor is only 2X, which means that the original material was diluted to the level of 1 part in one hundred, meaning that it’s still quite detectable. The unproven principles of homeopathy say that the more diluted something is, the more effective and they are often diluted to 1 part in a million (6X) or much lower (100X or more). One popular influenza remedy called Oscillococcinum is actually 200C, which means that it was diluted 200 times, each at a 100 fold dilution (that’s one part taken to a 400 zeros-fold dilution).

This may be why only some people have developed loss of smell from the Zicam products and not everyone who has used them. The unfortunate few may have been especially sensitive to the effects of zinc. If the label is to be believed, Zicam does contain a very small amount of zinc (one part in 100 parts of whatever the diluent is). In an accompanying warning letter to Matrixx, the FDA said that they had received “more than 130 reports of anosmia.” But the letter went on to say that FDA “is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell” associated with their Zicam products. The FDA has requested that Matrixx immediately submit all such reports to the agency. In addition, the FDA warned Matrixx that it was selling its products illegally because they are actually “drugs” according to the regulatory definition of a drug, which is a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Because Matrixx had not submitted data supporting the efficacy or safety of its products, once FDA classified them as “drugs,” they were no longer being marketed legally and were therefore subject to FDA seizure. On receipt of the warning letter, Matrixx voluntarily recalled its products although they said in a press release that “Matrixx Initiatives stands behind the science of its products and its belief that there is no causal link between its Zicam Cold Remedy intranasal gel products and anosmia.”

You might wonder how Matrixx was allowed to market its product in the first place (as well as all the other homeopathic remedies clogging the shelves)? It turns out that there’s an FDA policy on this with a guideline called “Conditions Under Which Homeopathic Drugs May be Marketed.” In general, all homeopathic products are allowed to be marketed with absolutely no testing of either their safety or their efficacy. None. In fact, even when the FDA determines there’s a safety problem, as it did with Zicam, it doesn’t use the enforcement discretion set forth in the guideline. Instead, it declares that the product is actually a “drug” and forces the company to withdraw it from the market and then either prove it’s safe and effective, with a new drug application, or else never market it again.

This is one of the reasons both homeopathic remedies and nutritional supplements, like herbs, vitamins and minerals, can be quite dangerous: They have not undergone any safety or efficacy testing. With all such products, you are at the mercy of the manufacturers and particularly the marketers who concoct these formulations and then sell them to an unsuspecting public. You basically have no idea what you are buying, whether it is either safe or effective, or bears any relationship whatsoever to the claims made on the label or in advertising. Anyone can throw together whatever mixture of herbs, vitamins and minerals they want and sell it essentially for whatever they want. That’s exactly how Airborne tablets, as one example, which I’ve railed about extensively in these pages, came into being. And they’re still proud of the fact that Airborne was developed by a second grade teacher with no medical or pharmacy background. She just believed that her particular formulation of herbs, vitamins and minerals would be effective (of course, it isn’t, but that doesn’t stop millions of people from falling for their scam).

If you’ve had problems from Zicam or any other homeopathic remedies or nutritional supplements, let us know by leaving a comment below so that others can learn from your experiences. We look forward to hearing from you.

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ABOUT THE AUTHOR

Ed Zimney, MD

Ed is a physician with more than 30 years of experience. He’s held positions in drug advertising review, drug safety surveillance, medical information and marketing with several bio/pharmaceutical companies.